Judge Bucks Bayer's Attempt to Seal Essure Documents
Alameda County Superior Court Judge Winifred Smith is likely to deny Bayer's motion to seal internal audit documents, having ruled tentatively that California law does not protect self-critical analysis from public disclosure.
February 05, 2020 at 06:56 PM
3 minute read
Bayer is poised to lose another attempt to keep documents confidential in the coordinated cases over Bayer's female sterilization device Essure as plaintiffs lawyers attempt to prove that the previous manufacturer of the implant hid evidence of its potential negative side effects.
In a tentative ruling issued Tuesday, Alameda County Superior Court Judge Winifred Smith denied Bayer's motion to seal internal audit documents from 2008 and 2015 regarding the permanent implant inserted into the fallopian tubes.
"Bayer argues that the documents should be sealed because public disclosure of the audit documents will discourage self-critical analysis," Smith wrote. "California law held that there is no self-critical analysis privilege. This California law suggests that self-critical documents are not confidential and can be both subject to discovery and filed in public files."
Smith said that Food and Drug Administration regulations around privilege also do not help the company make its case for confidentiality.
"After an investigation is commenced, the FDA protection for audit documents is not protected from disclosure like attorney-client information and is not protected from use by the FDA like subsequent remedial measure information," she wrote.
Smith heard arguments regarding the motion during a hearing Wednesday.
Alexandra Walsh, of Wilkinson Walsh in Washington, D.C., said that her client Bayer did not resist discovery of the documents with plaintiffs but said it was important to the FDA that these filings remained under seal. "It matters to the FDA, which has concluded for decades that the internal audits a company conducts should not be disclosed to the public," Walsh said. "The FDA itself does not review these audits. It's recognition that if these audits are made available to the FDA or made available on the public docket, that could chill the rigor of those audits."
Plaintiffs attorney Lori Andrus, of Andrus Anderson in San Francisco, agreed with Smith's tentative ruling and said she appreciated California law recognizes that the closer the parties get to the March 2 bellwether trial "the more important that sunshine is let into these proceedings."
The documents also don't qualify as confidential business information either, Smith tentatively ruled, since the commercial value of the write-ups from 2008 have likely gone stale and the company did not show evidence of an "overriding interest that overcomes the right of public access to the record."
Smith did not have any questions for the attorney on the motion and said she would take their arguments into consideration.
The motion follows Smith's November decision releasing 16 court documents and part of a deposition from a blanket protective order locking down the majority of the cases 70 million discovery documents.
Plaintiffs counsel are seeking to break through the protective order to help support their allegations that Essure's prior parent company, Conceptus, intentionally hid records detailing reported side effects including hair and tooth loss, chronic bleeding, miscarriages and death of both Essure recipients and their infants. Bayer took the implant off the market in 2018 for commercial reasons in the wake of thousands of reports of alleged defects to the FDA.
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